A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

Trial ID or NCT#

NCT03952078

Status

not recruiting iconNOT RECRUITING

Purpose

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

Official Title

A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Adult subjects age ≥18 years* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1* Histologically confirmed evidence of T-cell lymphoma* Measurable disease.* Adequate organ function.* At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.
Exclusion Criteria:
  1. * Treatment with systemic immunosuppressive medication.* History of allogeneic hematopoietic stem cell transplantation.* History of primary immunodeficiency, solid organ transplantation.* History of opportunistic infection within 180 days of starting study drug.* Females who are pregnant, lactating, or intend to become pregnant* History of invasive prior malignancy that required systemic therapy within last 3 years.* Concomitant use of strong inhibitors or inducers of CYP3A.

Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

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Contact

Elle Kim
650-387-4436